syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a stand-alone diagnostic device.

Device Description

The subject device syngo.CT Brain Hemorrhage is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians in analysis and prioritization of noncontrast head CT DICOM images by algorithmically identifying findings suspicious of acute intracranial hemorrhage. The subject device provides a pipeline for the analysis and identification of potential ICH as well as a finding notification mechanism.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided text:

Acceptance Criteria and Device Performance Study for syngo.CT Brain Hemorrhage

1. Table of Acceptance Criteria and Reported Device Performance

The document states a performance goal rather than strict acceptance criteria with defined thresholds. The acceptance was based on exceeding this goal.

Performance Metric	Performance Goal (Acceptance Criteria)	Reported Device Performance
Sensitivity	> 80%	92.8% (95% CI: 89.3%-95.2%)
Specificity	> 80%	94.5% (95% CI: 91.3%-96.5%)
Average Per-Case Processing Time	Comparable to predicate device	13.67 seconds (95% CI: 7.48-19.86 seconds)

2. Sample Size and Data Provenance

Test Set Sample Size: 600 anonymized head CT cases.
Data Provenance: The cases were collected from 5 sites in the US and Europe. The data was retrospective.
Case Distribution: Approximately equal distribution of positive (cases with ICH) and negative (cases without ICH) cases.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: 3
Qualifications: US board-certified neuroradiologists with more than 10 years of experience.

4. Adjudication Method for the Test Set

The ground truth was established by majority read of the 3 neuroradiologists. This implies a 2+1 adjudication, where if at least two experts agreed, that decision was taken as the truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The study described is a standalone performance study of the algorithm. Therefore, there is no information on how human readers improved with AI vs. without AI assistance. The device is intended solely for worklist prioritization and is not for diagnostic use or to alter images.

6. Standalone (Algorithm Only) Performance Study

Yes, a retrospective standalone performance study was conducted. The reported sensitivity and specificity values are for the algorithm only, without human-in-the-loop.

7. Type of Ground Truth Used

The ground truth was established by expert consensus (majority read of 3 US board-certified neuroradiologists).

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only describes the validation (test) set.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. It only details how the ground truth for the test set was created (majority read by 3 neuroradiologists).

Summary

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Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K203260

January 28, 2022

Trade/Device Name: syngo.CT Brain Hemorrhage Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: December 15, 2021 Received: December 17, 2021

Dear Tabitha Estes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203260

Device Name syngo.CT Brain Hemorrhage

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY FOR SYNGO.CT BRAIN HEMORRHAGE

K203260

Date Prepared: January 26th, 2022

Identification of the Submitter

Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869

Manufacturing Site Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany

Establishment Registration Number 3004977335

Submitter Contact Person:

Tabitha Estes Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 804-4553 Email: tabitha.estes(@siemens-healthineers.com

Alternate Contact: Alaine Medio

I. Device Name and Classification

Product Name: syngo.CT Brain Hemorrhage Propriety Trade Name: syngo.CT Brain Hemorrhage Classification Name: Radiological Computer-Assisted Triage and Notification Software Classification Panel: Radiology 21 CFR §892.2080 CFR Section: Device Class: Class II Product Code: QAS

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II. Predicate Device

Trade Name:	Accipiolx
510(k) Number:	K182177
Clearance Date:	07/26/2019
Classification Name:	Radiological Computer-Assisted Triage and Notification Software
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2080
Device Class:	Class II
Product Code:	QAS

III. Device Description

IV. Indications for Use

V. Comparison of Technological Characteristics with the Predicate Device

The differences and similarities between the above referenced predicate device are listed at a high-level in the following table:

Feature	Subject Device	Predicate Device	ComparisonTable
	syngo.CT Brain Hemorrhage	MaxQ-AI Accipiolx
Notification-only, parallelworkflow tool	Yes	Yes	Same
Intended User	Hospital networks and qualifiedclinicians	Hospital networks and qualifiedclinicians	Same
Setting	Acute Care	Acute Care	Same
Identify patients with aprespecified clinicalcondition	Yes	Yes	Same
Clinical condition	Intracranial hemorrhage	Intracranial hemorrhage	Same
Alert to finding	Yes; flagged for review	Yes; flagged for review	Same
Independent of standardof care workflow	Yes; No cases are removed fromworklist	Yes; No cases are removed fromworklist	Same
Modality	Non-contrast CT	Non-contrast CT	Same
Body Part	Head	Head	Same
Artificial Intelligencealgorithm	Yes	Yes	Same
Limited to analysis ofimaging data	Yes	Yes	Same

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Feature	Subject Device	Predicate Device	Comparison Table
Output	syngo.CT Brain Hemorrhage	MaxQ-AI Accipiolx	Same
	Suspected hemorrhage / No suspected hemorrhage	Suspected hemorrhage / No suspected hemorrhage

The subject device syngo.CT Brain Hemorrhage does not have changes in fundamental scientific technology compared to the predicate device. The post-processing software functionality remains unchanged from the subject device and the predicate device. The operating principle and the scientific technology are the same; therefore, Siemens believes that syngo.CT Brain Hemorrhage application is substantially equivalent to the predicate device.

VI. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing

Non-clinical tests (integration and functional) were conducted for syngo.CT Brain Hemorrhage during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The results of all conducted testing were found acceptable to support the claim of substantial equivalence.

Performance Evaluation of the Algorithm

The performance of the syngo.CT Brain Hemorrhage device has been validated in a retrospective standalone performance study. Sensitivity and specificity of syngo.CT Brain Hemorrhage in processing of non-contrast head CT have been analyzed by comparison to a ground truth established by majority read of 3 US board certified neuroradiologists with more than 10 years of experience. The data cohort consisted of 600 anonymized head CT cases from 5 sites in US and Europe with approximately equal distribution of positive (case with ICH) and negative (case without ICH) cases.

Sensitivity was observed to be 92.8% (95% CI: 89.3%-95.2%). Specificity was observed to be 94.5% (95% CI: 91.3%-96.5%). Thus, sensitivity and specificity exceeded the 80% performance goal.

The average per-case processing time was 13.67 seconds (95% CI: 7.48-19.86 seconds). This is comparable to the predicate device.

To conclude, syngo.CT Brain Hemorrhage is a safe and effective triage and notification device for intracranial hemorrhages which is substantially equivalent to the predicate device.

Siemens hereby certifies that syngo.CT Brain Hemorrhage will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce:

RecognitionNumber	ProductArea	Title of Standard	Date ofRecognition	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set; PS 3.1 - 3.20	06/27/2016	NEMA
13-79	Software	Medical Device Software -Software Life CycleProcesses; 62304:2006 (1st Edition)	01/14/2019	AAMI, ANSI,IEC
5-40	Software/Informatics	Medical devices – Application of riskmanagement to medical devices; 14971 SecondEdition 2007-03-01	06/27/2016	ISO
5-114	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2015	12/23/2016	IEC

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VII. Conclusion

syngo.CT Brain Hemorrhage has the same intended use and similar indication for use as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, clinical and non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. Siemens considers syngo.CT Brain Hemorrhage to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.

Regulation Number and Section

§ 892.2080 Radiological computer aided triage and notification software.

(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.